Role of Empagliflozin in Metabolic Changes Associated With Antiretroviral Therapy in Human Immunodeficiency Virus

What this Trial Is About

Researchers are evaluating the role of empagliflozin in treating obesity and metabolic complications in adults living with HIV who are receiving dolutegravir-based antiretroviral therapy. The study focuses on how empagliflozin might impact weight and other metabolic changes associated with antiretroviral treatment, especially given the increased risk of metabolic syndrome and cardiovascular disease in this population. This is a Phase 2 randomized trial aiming to address these important health challenges in people living with HIV. Participants are randomly assigned to one of two groups: one group will receive empagliflozin 10 mg once daily along with their standard dolutegravir-based antiretroviral therapy for six months, while the control group will receive a placebo plus the standard therapy. Both treatments are given orally, and the study includes a triple-blind design to ensure unbiased results. The trial carefully monitors participants over the 6-month treatment period. During the study, researchers will track changes in weight, total cholesterol, fasting blood glucose, HbA1c, kidney function, blood pressure, body mass index, waist circumference, CD4+ T-cell count, and HIV viral load. Assessments occur at baseline, 3 months, and 6 months as appropriate. Participants will provide informed consent and undergo regular evaluations to assess metabolic and immunologic changes, with the primary focus on weight change after six months. The study concludes in late 2027.

Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy